A Phase II Feasibility and Correlative Study of Probiotic Supplementation in Cancer Patients Receiving Chemotherapy or Tyrosine Kinase Inhibitors (TKIs)
This randomized phase II clinical trial studies probiotic supplementation in preventing treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may help prevent diarrhea caused by treatment with chemotherapy.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- dietary supplement : Lactobacillus plantarum strain 299v
- dietary supplement : Lactobacillus acidophilus probiotic
- dietary supplement : placebo
- dietary supplement : Bifidobacterium lactis probiotic supplement
- other : questionnaire administration
- other : laboratory biomarker analysis
- procedure : quality-of-life assessment
Phase: Phase 2
Ages Eligible For Study:
- Any patient with a documented malignancy initiating treatment including (as a single agent or in combination with other drugs) any one of the following cancer therapeutics: o Fluorouracil (5FU), capecitabine, irinotecan, paclitaxel, docetaxel, cabazitaxel, crizotinib, sorafenib, sunitinib, erlotinib, or lapatinib - Any pathologically confirmed malignancy for which the patient would receive any of the listed cancer therapeutics - Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2 - Patient must have an estimated life expectancy of at least 6 months - Absolute neutrophil count (ANC) > 1500 - Platelets > 100K - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x ULN (upper limit normal) - Serum bilirubin < 1.5 x ULN - Serum creatinine < 1.5 x ULN - Ability to understand and the willingness to sign a written informed consent document and comply with the treatment protocol